Novasep has invested $5.5 million to expand its highly potent active pharmaceutical ingredients (HPAPI) manufacturing capabilities at its Le Mans facility in France. The expansion has been fully qualified and is now being used to scale up validation of a commercial ADC (antibody drug conjugate) payload.
HPAPI products must be produced under very strict regulatory conditions to prevent API substance from cross contamination and protect operators from the highly active properties of these products. CMOs increasingly need to upgrade their facilities with higher containment capabilities to meet these needs.
The Le Mans production facility combines chemical and purification capabilities to manufacture potent and extremely potent ADC payloads at commercial scale with an OEL (occupational exposure limit) lower than 30 ng/m3 at multi-kg scale per batch. The production suite can also perform cryogenic chemistry at -60°C in hastelloy reactors.
“We are pleased to see the Le Mans facility commissioned, fully operational and successfully FDA audited,” said Thierry Van Nieuwenhove president of the Synthesis Business unit at Novasep. “There is a high demand from the pharmaceutical industry for CMOs to manufacture potent molecules for use in drugs that improve efficacy and reduce side effects. Novasep has the development and manufacturing capacity, level of specialization and experience to safely address the needs of this market.”